PMDA drug package insert

ロキソニンゲル1%

PMDA Prescription drug · 第一三共株式会社 · package insert Mar 5, 2025

Key facts

Brand names ロキソニンゲル1%
Nonproprietary names ロキソプロフェンナトリウム水和物
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category 経皮吸収型鎮痛・抗炎症剤
Therapeutic category codes 872649
YJ codes 2649735Q1020
Approval numbers 22200AMX00377
Package insert edition 第3版
Package insert date Mar 5, 2025
PMDA document key 430574_2649735Q1020_1
PMDA company code 430574

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • Yes PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)